# K083165: Palomar Aspire Laser Platform

- Pathway: 510(k) (Traditional)
- Applicant: Palomar Medical Products, Inc.
- Decided: Feb 13, 2009 after 109 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K943450 (1995). 374 ancestors in all.
No later device cites it as a predicate yet.
0 of 375 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081416: Palomar Aspire Laser Platform, Palomar Medical Products, Inc. (2008) Summary page 1.
- K080567: Palomar Aspire Laser Platform, Palomar Medical Products, Inc. (2008) Summary page 1.
- K070388: Profile Multi-Platform System, Sciton, Inc (2007) Summary page 1.
- K080121: Cynosure Smartlipo Multiwavlength Laser, Cynosure, Inc. (2008) Summary page 1.
- K081015: Ceralas D 980NM Diode Laser, Models D15 and D25, Biolitec, Inc. (2008) Summary page 1.

## Indications for use
The Palomar Aspire TM Laser Platform is intended for coagulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, and subcutaneous tissue. The device is further indicated for laser assisted lipolysis.

Source page: https://510kreport.com/device/K083165
Methodology: https://510kreport.com/methodology